Why Your Probiotic Softgel Is Probably Dead on Arrival

A probiotic label promises live organisms at a count, but the organisms have to survive manufacture, storage and stomach acid to be worth anything. Most probiotic products lose a large share of their count before the consumer opens the bottle — and a softgel, with its heat and moisture during production, is one of the harder formats to get right. Here is what determines whether your strain survives.

On this page: What Kills Probiotics · Engineering Survival · Choosing and Claiming

What Kills Probiotics

1. What happens to probiotics during manufacturing?
   Heat, moisture and shear all reduce viability. A softgel is filled hot and sealed, so the organisms must survive a thermal process and then sit in a matrix that may hold residual moisture. Strains differ widely in how well they tolerate this.
2. What happens during storage?
   Viability declines over time, and the rate depends on temperature, humidity and packaging. A product stored in a hot warehouse or a humid bathroom can lose most of its count well before the printed expiry date.
3. What happens in the stomach?
   Stomach acid destroys a large proportion of unprotected organisms. Without an enteric coating or a protective matrix, a substantial share of the dose never reaches the intestine, however good the count on the label.
4. So what is the number that actually matters?
   The viable count at end of shelf life, after storage, and the share that survives gastric transit. A label CFU measured at manufacture is the most flattering number available and the least useful to your customer.

Engineering Survival

1. What formulations protect probiotics?
   Microencapsulation, enteric coating, spore-forming strains, and a low-water-activity matrix. Each addresses a different threat: the capsule protects through the stomach, encapsulation protects through moisture and heat, and spore formers are inherently robust.
2. Is a hard capsule better than a softgel for probiotics?
   Often yes, because it avoids the heat and moisture of softgel production. A hard capsule can also be enteric-coated more easily. Where a softgel is chosen for other reasons — oil-soluble co-ingredients — the formulation has to work harder.
3. Does overage solve the problem?
   Partly. Factories add an overage at manufacture so the count is still on target at expiry. It works, but it costs money and it does not fix gastric survival. Overage and protection address different halves of the problem.
4. How do I verify the count?
   Ask for assay data at release and at end of shelf life, from a third-party lab, on the finished product in its actual packaging. If a supplier can only give you the raw-material potency, you do not know what your customer is getting.

Choosing and Claiming

1. What should I ask before choosing a strain?
   Ask for the strain’s documented tolerance to heat, moisture and acid, and whether the factory has run it in your chosen format before. Some strains are well suited to gummies or softgels; others are not, and no amount of overage fixes that.
2. How should I choose the CFU claim?
   Claim what you can hold at end of shelf life, not what you can load. A lower, warranted number is a stronger product than a high number that assays low — and it protects you from a refund problem as well as a compliance one.
3. Does packaging matter?
   Yes. Moisture and oxygen barriers in the bottle or blister make a measurable difference to viability. Ask what packaging the stability data was generated in, and match it.
4. What about storage instructions?
   If the product requires refrigeration for the count to hold, say so on the label. Claiming a shelf-stable count you cannot support is the fastest route to a complaint and a reprint.

Related Reading

See softgel manufacturing and capsule manufacturing for the two formats, and microencapsulation explained for the technique behind protection.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.